FDA label 57648169-e767-4268-a487-40c8cb5448fc

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID: 64b270f0-ed4e-49b7-a6fa-cb801178fc5e
SPL ID: 57648169-e767-4268-a487-40c8cb5448fc
Version: 6
Effective date: 2019-08-20
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:16:55

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		57648169-e767-4268-a487-40c8cb5448fc	id
spl set id		64b270f0-ed4e-49b7-a6fa-cb801178fc5e	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNING WARNING : STOP USE AND CALL A DOCTOR if symptoms persist or worsen. CONTAINS ALCOHOL: in case of accidental overdose, consult a poison control center immediately IF PREGNANT OR BREAST FEEDING , consult a healthcare professional before use. OTHER INFORMATION : Tamper resistant for your protection. Use only if safety seal is intact.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.